Medical grafting methods and apparatus

ABSTRACT

Methods and apparatus for making an anastomotic connection between first and second tubular fluid conduits are provided. For example, a connector may be configured for attachment to the first and second tubular fluid conduits and have an interior thereof substantially accessible to the interior of the first tubular fluid conduit. The connector may be configured for annular enlargement. An expandable structure is provided having a first portion configured to annularly enlarge the connector by engaging the interior of the connector. A second portion may be configured to extend through an opening in the medial portion of the first tubular fluid conduit.

This application is a division of U.S. patent application Ser. No.09/324,997, filed Jun. 2, 1999, which is a nonprovisional of U.S.provisional patent application Ser. No. 60/123,482, filed Mar. 9, 1999.Both of these prior applications are hereby incorporated by referenceherein in their entireties.

BACKGROUND OF THE INVENTION

This invention relates to medical methods and apparatus, and moreparticularly to methods and apparatus for installing a tubular graft ina patient for such purposes as bypassing an occlusion or narrowing inthe patient's tubular body structure.

The invention is applicable to making anastomotic connections betweenall body conduits. For example, the invention also has application forattaching coronary artery bypass grafts. Specifically, connectionmethods and apparatus are provided for attaching the graft ends to thecoronary artery and the aortic artery. In the case of the internalmammary artery, connection is required at the coronary artery only.

Conventional coronary artery bypass grafting requires the heart andassociated vessels to be accessed through the center of the chest bysplitting the sternum (e.g., median sternotomy) or through the side byseparating the ribs (e.g., thoracotomy). The heart is typically stoppedduring this process, and the patient is placed on cardiopulmonarybypass. These procedural steps are typically performed in order to allowthe physician to safely and precisely sew the grafts with sutures to theexposed arteries as deemed necessary. However, this procedure mayinvolve risks to the patient attributable to the magnitude of theincision required and the procedure of stopping the heart, which allowthe physician the access to stitch on a non-beating heart, i.e.,“static” stitching. This procedure may also be associated with variouscomplications, including stroke, heart block, and long patient recoverytimes. Another factor is the considerable operation time involved due tothe criticality of individual hand sewing of each graft end required bythe suture process. The precision with which the grafts are sewn mayinfluence the ultimate patency term for the graft.

Typical prior art procedures have been described by Heartport, forexample, which attempts to connect vessels through ports insertedbetween the ribs but also requires the heart to be stopped and thegrafts be sewn in place. Cardiothoracic Systems describes a procedurewherein the heart is allowed to beat, but full access to the heart isrequired as well as hand sewing of the graft segments to the beatingheart. Other procedures describe the use of robots and automatedmechanical assist devices to complete a sewn anastomosis on beatinghearts or through small incisions.

It is thus an advantage of the current invention to overcome some ofthese difficulties associated with cardiac surgery.

It is an advantage of the invention to eliminate the need to stop theheart.

It is a further advantage of the invention to reduce significantly thesize of the incision and to reduce the exposure of the heart and aortanecessary to perform the surgery.

It is still a further advantage of the invention to reduce the timenecessary to perform the anastomosis procedure by eliminating thetime-consuming task of manually suturing the vessels together.

It is also an advantage of the invention to provide an improved andconsistent anastomosis result, without the reliance on the technique andskill of the physician.

SUMMARY OF THE INVENTION

These and other advantages of the invention are accomplished inaccordance with the principles of the invention by providing anapparatus and methods for use in making an anastomotic connectionbetween two tubular body fluid conduits in a patient, the connectorbeing configured for attachment to the first and second tubular fluidconduits. In one embodiment of the invention, one of the tubular fluidconduits defines an opening extending between the exterior and theinterior of the conduit. The connector may have an interior which issubstantially accessible to the interior of the first tubular fluidconduit, and is also configured for annular enlargement. An expandablestructure is provided having a first portion configured to annularlyenlarge the connector by engaging the interior of the connector. In apreferred embodiment, a second portion of the expandable connector isconfigured to extend through the opening in the medial portion of thefirst tubular fluid conduit.

According to a preferred embodiment, a portion of the connector may beconfigured for attachment to the axial end of the first tubular fluidbody conduit and be substantially coaxial therewith. The connector mayinclude members having free end portions that are configured topenetrate the first tubular body conduit at locations that are axiallyspaced around the connector. An axial portion of the connector may beconfigured for insertion through an opening in a side wall of the secondtubular fluid conduit. The connector may include members having free endportions that are directed radially outward and are configured to engagethe exterior of the side wall of the second tubular fluid conduit when apredetermined axial portion of the connector has passed through theopening in the side wall of the second tubular fluid conduit.

In order to remotely expand the first, distal portion of the expandablestructure, the expandable structure also includes a third, proximalportion for remotely introducing fluid or pressurized air. A taperedstructure may be provided for dilating the opening in the second fluidtubular conduit by advancing the tapered structure through the opening.A longitudinal member may be provided which is configured to extendbetween the first tubular fluid conduit and the second tubular fluidconduit. In a preferred embodiment, the longitudinal member isconfigured to extend through the opening in the second tubular fluidconduit and along the lumen thereof. The tapered structure may alsoinclude an elongated tubular structure, e.g., a catheter-like structure,axially extending from an end portion of the tapered structure andcoaxial with the longitudinal member. The tapered structure may beconfigured to be advanced into and along the interior of the secondtubular fluid conduit after dilating the opening in the side wallthereof. Alternatively, the tapered structure is configured to beadvanced into and along the interior of the first tubular fluid conduitafter dilating the opening in the side wall of the second tubular bodyconduit. In such a case, the connector may have annularly expandedsufficiently to allow the tapered structure to pass through the interiorof the connector. As an alternative or in addition to the taperedstructure, a second expandable structure, such as a balloon, may beprovided which is configured to dilate the opening in the second tubularfluid conduit.

Further in accordance with the invention, apparatus and methods areprovided to make a second anastomotic connection between the firsttubular fluid conduit and a third tubular fluid conduit. The firsttubular fluid conduit defines first and second axial end portions. Theapparatus further includes a second connector configured for attachmentto the first and third tubular fluid conduits and having an interiorthereof substantially accessible to the interior of the first tubularfluid conduit. The second connector is also configured for annularenlargement. A second expandable structure is provided having a first,distal portion configured to annularly enlarge the second connector byengaging the interior of the second connector, and having a portionconfigured to extend through the opening in the medial portion of thefirst tubular fluid conduit. The distal portion of the first expandablestructure and the distal portion of the second expandable structure areindependently and/or simultaneously expandable.

The first tubular fluid conduit may be a natural body conduit, such asthe saphenous vein or the internal mammary artery, and the opening in amedial portion thereof may be a natural side branch. Alternatively, thefirst tubular fluid conduit may be an artificial graft conduit.

Further apparatus and methods for installing a tubular graft conduitbetween first and second spaced locations in a patient's tubular bodystructure are disclosed. Apparatus in accordance with the invention mayinclude first and second connectors attached to the axial ends of thetubular graft conduit and having interior portions substantiallyaccessible to the interior of the tubular graft conduit. A firstexpandable structure may be provided having a first balloon portion forannularly expanding a portion of the first connector by engaging theinterior of the first connector and a first elongated structure forremotely expanding the first balloon member. The first expandablestructure may be provided with an axial opening extending therethrough.A second expandable structure may also be provided having a secondballoon portion for annularly expanding a portion of the secondconnector by engaging the interior of the second connector and a secondelongated structure for remotely expanding the second balloon member. Aportion of the second expandable structure may extend coaxially throughthe axial opening in the first expandable structure.

A method of installing the tubular graft conduit between first andsecond spaced locations in a patient's tubular body structure isdisclosed, which includes providing an aperture through a wall of thetubular body structure at the first location with a distal portion of anelongated structure inserted into and along a lumen of the tubular bodystructure to the first location. A graft is provided having first andsecond connectors attached to axial ends of the graft.

The graft may be passed along the lumen of the tubular body structurethrough the wall at one of the first and second locations to the otherof the locations. A further step may be to attach axial end portions ofthe graft to the tubular body structure adjacent the first and secondlocations by annularly expanding the first and second connectors.According to a preferred embodiment, the step of attaching axial endportions of the graft to the tubular body structure by annularlyexpanding the first and second connectors may be achieved by expandingfirst and second expandable structures positioned adjacent the interiorsof the first and second connectors.

In accordance with a preferred embodiment, the step of attaching axialend portions of the graft to the tubular body structure may includeannularly expanding a first axial portion of the first connector spacedfurthest from the first location, inserting a second axial portion ofthe first connector into the tubular body structure at the firstlocation such that the first axial portion of the first connectorremains outside the tubular body structure, and annularly expanding thesecond axial portion of the first connector positioned inside thetubular body structure. In order to deploy the connector as describedabove, the method may include providing a second elongated structurehaving a lumen, coaxially positioned to surround an axial portion of thefirst connector. When the second elongated structure is provided in anembodiment in accordance with the invention, the first axial portion ofthe first connector may be exposed from the lumen of the secondelongated structure while retaining the second axial portion within thelumen of the second elongated structure, before annularly expanding thefirst axial portion of the first connector. Moreover, before inserting asecond axial portion of the first connector into the tubular bodystructure at the first location, the distal end portion of the firstelongated structure may be retracted into the tubular body structure. Inaddition, before annularly expanding the second axial portion of thefirst connector positioned inside the tubular body structure at thefirst location, the second portion of the first connector may be exposedfrom the lumen of the second elongated structure.

Further features of the invention, its nature and various advantageswill be more apparent from the accompanying drawings and the followingdetailed description of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified view, in partial section, of the apparatus inaccordance with the invention.

FIG. 1(a) is a simplified sectional view, similar to FIG. 1,illustrating an alternative embodiment of the apparatus in accordancewith the invention.

FIG. 2 is a simplified planar development of the structure of anillustrative embodiment of a connector constructed in accordance withthis invention.

FIG. 3 is a simplified elevational view of the actual structure of theconnector which is shown in planar development in FIG. 2.

FIG. 4 is a simplified planar development of the structure of FIGS. 2-3showing that structure's capacity for annular enlargement in accordancewith the invention.

FIG. 5 is a simplified planar development of the structure of a secondillustrative embodiment of a connector constructed in accordance withthis invention.

FIG. 6 is a simplified elevational view of the actual structure of theconnector which is shown in planar development in FIG. 5.

FIG. 7 is a simplified planar development of the structure of FIGS. 5-6showing that structure's capacity for annular enlargement in accordancewith the invention.

FIG. 8 is simplified view in partial section of the structure of FIG. 7with additional illustrative apparatus shown in FIG. 1 for use indelivering and deploying the FIG. 6 structure in a patient in accordancewith the invention.

FIG. 9 is a simplified sectional view showing an early stage in themethod in accordance with the invention.

FIG. 10 is a simplified sectional view similar to FIG. 9, showing alater stage in the method in accordance with the invention.

FIG. 11 is a simplified sectional view similar to FIG. 10, showing astill later stage in the method in accordance with the invention.

FIG. 12 is a simplified sectional view, showing the use of apparatus inan expanded configuration accordance with the invention.

FIG. 12(a) is an enlarged sectional view, showing the apparatus of FIG.12 in an unexpanded configuration in accordance with the invention.

FIG. 13 is a simplified sectional view, showing an early stage in theuse of the FIG. 1 apparatus and the FIG. 2 connector in accordance withthe invention.

FIG. 13(a) is a simplified sectional view, similar to FIG. 13, showingan alternative embodiment of the use of the FIG. 1 apparatus and theFIG. 2 connector in accordance with the invention.

FIG. 14 is a simplified sectional view similar to FIG. 13, showing alater stage in the use of the FIG. 1 apparatus in accordance with theinvention.

FIG. 15 is a simplified sectional view similar to FIG. 13, showing astill later stage in the use of the FIG. 1 apparatus in accordance withthe invention.

FIG. 16 is a simplified sectional view similar to FIG. 13, showing theend result of using the FIG. 1 apparatus and the FIG. 2 connector inaccordance with the invention.

FIG. 16(a) is a simplified sectional view similar to FIG. 16, showingthe alternative embodiment of FIG. 13(a) in accordance with theinvention.

FIG. 17 is a simplified enlarged sectional view, showing an early stagein the use of the FIG. 1 apparatus and the FIG. 5 connector inaccordance with the invention.

FIG. 18 is a simplified enlarged sectional view similar to FIG. 17,showing the end result of using the FIG. 1 apparatus and the FIG. 5connector in accordance with the invention.

FIG. 19 is a simplified sectional view, showing the end result of usingthe FIG. 2 connector and the FIG. 5 connector in accordance with theinvention.

FIG. 20 is a simplified view, in partial section, of an alternativeembodiment of the apparatus in accordance with the invention.

FIG. 20(a) is an enlarged sectional view of a portion of the apparatusof FIG. 20 in accordance with the invention.

FIG. 21 is a simplified sectional view showing an early stage in themethod in accordance with the invention.

FIG. 22 is a simplified sectional view similar to FIG. 21, showing alater stage in the method in accordance with the invention.

FIG. 23 is a simplified sectional view similar to FIG. 21, showing astill later stage in the method in accordance with the invention.

FIG. 24 is a simplified sectional view similar to FIG. 21, showing yet alater stage in the method in accordance with the invention.

FIG. 25 is a simplified sectional view, showing an early stage in theuse of the FIG. 20 apparatus, the FIG. 2 connector, and the FIG. 5connector in accordance with the invention.

FIG. 26 is a simplified sectional view similar to FIG. 25, showing alater stage in the use of the FIG. 20 apparatus in accordance with theinvention.

FIG. 27 is a simplified sectional view showing a portion of the FIG. 25view, showing a still later stage in the use of the FIG. 20 apparatus inaccordance with the invention.

FIG. 28 is a simplified sectional view similar to FIG. 27, showing theend result of using the FIG. 20 apparatus and the FIG. 5 connector inaccordance with the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Although the invention has other possible uses, the invention will befully understood from the following explanation of its use in providinga bypass around a narrowing in a patient's vascular system. In additionto providing a coronary artery bypass, the invention is useful anywherein the patient's circulatory system including renal veins and arteries,femoral veins and arteries, abdominal aorta, peripheral bypass in thearms and legs of the patient, A-V shunts, carotid artery, and any othercirculatory system bypass. The bypass graft may be a vein, radialartery, internal mammary artery (IMA), other native vessel, or syntheticconduit.

FIG. 1 illustrates apparatus 100 for installing a graft 104 to thepatient's vascular system. Apparatus 100 includes a connector structure10 useful for making the connection between the graft 104 and thecoronary artery (not shown in the FIG.), typically referred to as the“distal” connection. Connector structure 12 is particularly useful formaking the connection between the graft 104 and the arterial bloodsource, such as the aorta (not shown in the FIG.). The invention is alsouseful when the arterial blood source is the internal mammary artery(IMA) and a single connection is made, i.e., connector 10 is used toconnect a severed portion of the IMA to the coronary artery.

Connector structures 10 and 12 are deployed and installed by graftinstalling apparatus 14 and 16, respectively. As will be described ingreater detail below, graft installing apparatus 14 and 16 actuateconnector structures 10 and 12 by the expansion of connector expandingballoons 18 a and 18 b, via the introduction of fluid from proximalportions 19 a and 19 b to balloon catheters 17 a and 17 b, respectively.In a preferred embodiment of the invention, graft 104 may be a naturalvessel that has been excised or relocated within the patient, such asthe saphenous vein or IMA. The saphenous vein, for example, has aplurality of openings, such as side branches 105, that normally allowfluid flow between surrounding tissue and the vein itself. Many of theseside branches, i.e., branches 105 a and 105 b, are typically sealed bytying off or stapling. However, at least one of the side branches, i.e.,branches 105 c and 105 d, remain in fluid communication with the mainlumen 106 of the graft 104. The open side branches 105 c and 105 dpermit access to the interior lumen 106 of graft 104 and the interior ofconnectors structures 10 and 12. Use of the open side branches tointroduce instrumentation into the interior lumen of graft conduit 104for the purposes described above may reduce the trauma to the graftsegment by obviating the need for a venotomy or other incision in thegraft. When synthetic graft materials are used, the graft may bemanufactured with side branches or openings to permit access to theinterior of the graft in a substantially similar manner. Connectors 10and 12 may be deployed individually or simultaneously, as operativeconditions may suggest or the physician's evaluation may deemadvantageous. Connectors 10 and 12 are expanded simultaneously bysimultaneous expansion of balloons 18 a and 18 b. Individual expansionof connectors 10 and 12 is achieved by individual expansion of singleones of balloons 18 a and 18 b.

FIG. 1 illustrates graft installing apparatus 14 and graft installingapparatus 16 passing through open side branches 105 d and 105 c,respectively. It is understood that graft installing apparatus 14 mayaccess the interior 106 of graft 104 and the interior of connector 10through an axial end portion 107 of graft 104, as illustrated in FIG.1(a). The approach of accessing the connector 10 through an axial endportion 107 of the graft 104 may be advantageous when an anastomosis isperformed at a first end portion of the graft 104, and subsequently at asecond end portion. During such a procedure, the first connector may beaccessed through an axial end portion of graft 104, as shown in FIG.1(a). The second connector may then be accessed through a side branch,such as side branch 105 c, as shown in FIG. 1.

FIG. 2 shows a planar development of what is actually an integral,one-piece (unitary), annular connector structure 10. Structure 10 issubstantially identical to the connector described in Swanson et al.U.S. Pat. No. 6,113,612, which is incorporated by reference in itsentirety herein, and the differences are noted herein. In particular,the left and right edges of the structure shown in FIG. 2 are actuallyjoined to and integral with one another. Thus the actual structure is asshown in FIG. 3, although FIG. 2 is useful to more clearly reveal thedetails of various features of the structure. A central longitudinalaxis 12 about which structure 10 is annular is shown in FIG. 3.

An illustrative material for structure 10 is 304 stainless steel. Otherexamples of suitable materials include tantalum, tungsten, platinum, andnitinol. Structure 10 may be advantageously produced by starting with asingle, unitary metal tube and removing selected material until only thestructure shown in FIG. 3 remains. For example, laser cutting may beused to remove material from the starting tube in order to producestructure 10. Although connector 10 can be made in various sizes forvarious uses, a typical connector has an initial outside diameter in therange from about 0.040 to about 0.065 inches, an initial length of about4.0 mm, and a material thickness of about 0.004 inches.

Connector 10 may be described as including axially spaced first andsecond portions 20 and 40, respectively. First portion 20 includes afirst plurality of annularly spaced members 22 that in this case havefree end portions 24 that are sharply pointed and that point towardssecond portion 40. In addition, first portion 20 also includes a secondplurality of annularly spaced members 26, preferably having free endportions 28 that are sharply pointed and point towards second portion40. Each of members 22 and 26 is deflectable radially out from theremainder of structure 10 as shown, for example, in FIG. 3. This outwarddeflection is preferably at least partly plastic.

Second portion 40 also includes a plurality of annularly spaced members42 that in this case have free end portions 44 that are sharply pointedand that point toward first portion 20. Each of members 42 isdeflectable radially out from the remainder of structure 10 as shown,for example, in FIG. 3. Again, this outward deflection is preferably atleast partly plastic.

The above-mentioned outward deflection of elements 22, 26 and 42 can beproduced by putting the connector on a mandrel and prying elements 22,26 and 42 radially outward. Elements 22, 26 and 42 act as retentionmeans for securing the connector 10 to the graft 104 as described below.It is understood that when artificial (synthetic) grafts are used,different retention means, such as suture loops, may be used.

Connector 10 is formed in such a way that it is annularly enlargeable(e.g., by inflation of a balloon that is temporarily disposed inside theconnector). The annularly expanded condition of connector 10 is shown inFIG. 4. The annular expansion of connector structure 10 is described ingreater detail in U.S. Pat. No. 6,113,612, incorporated by referenceabove. The annular expandability of connector 10 is provided by makingthe connector with a plurality of annularly adjacent, annularlyenlargeable cells. For example, a typical cell includes annularlyspaced, but adjacent, longitudinal members 50 a and 52 a, the axiallyspaced ends of which are connected to one another at 54 a and 56 a. Aplurality of these cells are connected side to side on connectorstructure 10. A representative one of another cell includes annularlyadjacent longitudinal members 60 a and 62 a, the axially spaced ends ofwhich are connected at 64 a and 66 a. These cells are connected side toside at portion 40 of connector structure 10. The structure is annularlyenlargeable by annularly enlarging these cells as shown, for example inFIG. 4. It will be appreciated that as structure 10 annularly enlarges,it generally axially shortens.

FIGS. 5-7 illustrate an alternative embodiment of a connector structure,i.e., connector structure 12, which is substantially similar toconnection structure 10 described above, and the connector described inU.S. Pat. No. 6,113,612, incorporated by reference above. Connector 12is advantageously useful in making the proximal anastomosis between thegraft and the aorta. Many of the differences between connector structure12 and connector structure 10, described above, are relevant to thedifferent characteristics of the aortic wall, which is thicker and morerigid than the coronary artery wall. The particular sizes andconfigurations of the connector structures described herein may bespecifically tailored to the type of conduit being anastomosed. Forexample, in the exemplary procedure, the aorta wall is greater than 2 mmthick and the coronary artery wall is usually less than 1 mm thick.Therefore, connector 10 and 12 are constructed to secure the graft tothe respective vessel walls.

Connector 12 may be described as including axially spaced first portion70, substantially identical to first portion 20 of connector 10, secondportion 80, substantially identical to second portion 40, and thirdportion 90. First portion 70 includes a first plurality of annularlyspaced members 72 that in this case have free end portions 74 that aresharply pointed and that point towards second portion 80. Second portion80 includes a plurality of annularly spaced members 82 that are sharplypointed and point towards first portion 70. In addition, third portion90 includes a plurality of annularly spaced members 92, preferablyhaving free end portions 94 that are sharply pointed and point towardssecond portion 70, and in substantially the same direction as members72. Each of members 72, 82 and 92 is deflectable radially out from theremainder of structure 12 as shown, for example, in FIG. 6. This outwarddeflection is preferably at least partly plastic.

Connector 12 is annularly enlargeable as described above for connector10. The annularly expanded condition of connector 12 is shown in FIG. 7.As described for connector 10, connector 12 is provided with annularlyadjacent, annularly enlargeable cells. Connector 12 also defines aseries of enlargeable cells defined by adjacent longitudinal members 67a and 68 a, the axially spaced ends of which are connected at 66 a and69 a.

FIG. 8 illustrates exemplary connector 12 positioned with respect tograft installing apparatus 16. In particular, balloon 18 b in itsuninflated configuration is positioned within the interior of connector12. The remainder of the graft installing apparatus (e.g., ballooncatheter 17 b) extends within lumen 106 and through side branch 105 c.

Graft 104 is positioned annularly around the first portion 70 and thirdportion 90 of connector 12. Graft 104 may be a natural body conduit,such as the saphenous vein or IMA, or an artificial graft conduit, or acombination of natural and artificial conduits. Graft conduit 104 isplaced on connector 12 such that radially outwardly deflected members 72and 92 penetrate and pass through the side wall of graft 104. The graftattachment is described in greater detail in U.S. Pat. No. 6,113,612,incorporated by reference above. By positioning the graft conduit 104around connector 12, the interior of connector 12 is accessible, incommunication with, or open to the interior lumen of graft conduit 104.It is understood that a portion of the connector 12 may be alternativelypositioned outside the graft conduit 104; however, a portion of theconnector 12 should remain accessible from the interior of the graft104.

Graft conduit 104 may be installed in the patient and attached byconnectors 10 and 12 by methods described herein. The exampleillustrates the process of connecting graft 104 to the aorta 200 and thecoronary artery 202 downstream of the narrowing 204 of the patient'sheart H. According to a first method, illustrated in FIGS. 9-11, a guidemember is installed from inside the coronary artery 202 to the outside,and assists in the installation of the graft 104 and the connector 10.The installation of the guide member is described in greater detail inGoldsteen et al. U.S. Pat. No. 5,976,178 and Berg et al. U.S. patentapplication Ser. No. 09/187,364 (293/036), filed Nov. 6, 1998, both ofwhich are incorporated by reference in their entirety herein. As FIG. 9illustrates, a first guide wire 150 is introduced in the patient'scirculatory system via a remote location, such as the femoral artery(not shown). Guide wire 150 is advanced from the aorta 200 into thecoronary artery 202 having a narrowing 204. Guide wire is preferablyadvanced through the narrowing 204.

With continued reference to FIG. 9, a catheter or catheter-likestructure 152 is introduced into the patient over and along guide wire150, once wire 150 is positioned across narrowing 204. Guide wire 150facilitates passage of the distal portion of catheter 152 throughnarrowing 204. As shown in FIG. 9, catheter 152 substantially followsthe contours of wire 150.

An end portion 154 of catheter 152 is preferably constructed to form alaterally extending arch as shown in FIG. 10 when guide wire 150 iswithdrawn from catheter 152. For example, catheter 152 may be made sothat it resiliently tends to form an arch of a predetermined lateralextent when it is freed from the straightening effect of guide wire 150.An internal lumen (not shown) preferably extends along the entire lengthof the catheter and is used to allow the catheter 152 to track overguide wire 150 as described above, and to subsequently guide alongitudinal piercing structure to the point on the wall of artery 202where it is desired to connect one end of a bypass graft.

As shown in FIG. 10, a distal portion 154 of the catheter 152 may beconfigured to deflect or curve to the side when guide wire 150 iswithdrawn as described in U.S. patent application Ser. No. 09/187,364,or alternatively the distal end of the lumen within the catheter may beshaped to deflect the guide wire laterally, as described in U.S. Pat.No. 5,976,178, both of which are incorporated by reference above. As yetanother alternative, the lumen in catheter 152 may have a side branchwhich exits from the side wall of the catheter at or near the apex of anarch in the catheter adjacent the coronary artery wall, as described inU.S. patent application Ser. No. 09/187,364 (293/036), incorporated byreference above.

As illustrated in FIG. 11, a subsequent step involves inserting anelongated piercing structure, or guide member 160 (e.g., primarily ametal wire or wire-like structure), into catheter 152 along the lumenthereof formerly used for guide wire 150. Because catheter portion 154is now arched as shown in FIGS. 10-11, the distal end of guide member160 tends to follow the lumen of catheter 152 and into contact with theinterior surface of the side wall of coronary artery 202. The distal tipof guide member 160 is sufficiently sharp and guide member 160 issufficiently stiff that the distal tip of guide member 160 can be pushedout through the coronary artery wall tissue.

FIGS. 12-12(a) illustrate a preferred embodiment in which an expandablemember may be used in a further step of the procedure. An expandablemember, such as aperture dilating balloon 170, may be provided on thedistal end of catheter 172. Catheter 172 is advanced over and alongguide member 160, through the vascular system, to the anastomotic site.In the example, balloon 170 is advanced through the aorta 200, into thecoronary artery and through the narrowing 204. As shown in FIG. 12(a),balloon 170 is inserted through the aperture in the coronary artery wallmade by guide member 160. Balloon 170 passes through the aperture in itsunexpanded state. The balloon 170 is subsequently expanded by theintroduction of fluid or air into catheter 172, as shown in FIG. 12, inorder to controllably dilate the aperture in the wall of the coronaryartery 202 to a size which may be suitable for the requirements of thedistal connector or other apparatus useful to make the anastomosis.

FIG. 13 illustrates additional apparatus which may be used in a furtherstep of the procedure. A gradually tapered nose portion or sheath, suchas nose portion 180, may be provided having a substantially conicalouter surface. Nose portion 180 surrounds the distal portion of balloon18 a and connector 10. More particularly, nose portion covers outwardlyextending members 42 with free ends 44. This geometry allows optimalpassage across a body conduit wall (e.g., a coronary artery wall asshown in FIG. 13 and described below) with minimal wall damage, withminimal force being required, and with no catching or snagging on thewall. An inside portion of nose portion 180 may be shaped to receiveballoon 18 a, connector 10, and a distal portion of graft 104.

According to a first embodiment, portion 180 is attached to a catheter182 adjacent the narrow distal end of portion 180 and extends distallyfrom portion 180. Catheter 182 may be introduced over guide wire 160from a surgical access opening. Catheter 182 would subsequently beadvanced over guide wire 160 until it exits the patient at the remotelocation where the guide wire 160 exits the patient, e.g., the legadjacent the femoral artery. This configuration, illustrated in FIG. 13,allows the nose portion 180 to be pulled upstream within the coronaryartery 202, as will be described in greater detail below. According toan alternative embodiment, portion 180′ may be connected to a catheterportion 182′ which extends proximally from portion 180′ and into graft104 and graft installing apparatus 14 (FIG. 13(a)). This configurationpreferably enables portion 180′ to be withdrawn proximally into graft104 after completion of the anastomosis.

With continued reference to FIG. 13, a typical use of apparatus 14 andnose portion 180 as shown is to deliver graft 104 for connection to anaperture in a side wall of a patient's tubular body conduit, e.g., acoronary artery 202 requiring a bypass graft. A surgical access openingis made in the patient adjacent the anastomotic site in order to insertthe distal end portion of graft installing apparatus 14 (e.g., balloon18 a), graft 104 and connector 10 into the patient. Apparatus 14 ispositioned such that a portion of apparatus 14 passes through a sidebranch 105 d of graft 14 to access an interior portion of connector 10.

Guide member 160 may be inserted into an axial lumen at the distalportion of balloon 18 a. The tapered nose portion 180 is then graduallyforced into the aperture as illustrated by the arrow (e.g., by usingballoon 18 a to push portion 180 distally into the aperture) to dilatethe aperture. The natural elastic recoil of the conduit 202 side walltissue may continue to keep the aperture sealed or substantially sealedaround portion 180.

As illustrated in FIG. 14, nose portion 180 is pushed far enough intothe aperture in the side wall of conduit 202 so that connector 10 ispart way through the aperture. The second plurality of members 26 ofconnector 10 are directed radially outward and engage the wall ofconduit 202 after connector 10 has passed a predetermined distance intothe aperture. Thus members 26 act as “stops” to assist in thepositioning of connector 10 with respect to conduit 202.

FIG. 15 illustrates that the next step is to push nose portion 180farther into conduit 202 (e.g., by pulling catheter 182 furtherupstream). This causes distal nose portion 180 to separate fromconnector 10, thereby exposing the connector and leaving it in theaperture through the conduit 202 side wall.

With continued reference to FIG. 15, the next step in use of apparatus14 is to inflate balloon 18 a. The balloon is typically sized to aspecific anastomosis size (e.g., 3 millimeters diameter, 4 millimetersdiameter, etc.). Inflation of the balloon forces connector 10 toannularly enlarge by enlarging cells 50/52/54/56 and 60/62/64/66 in theannular direction (See, FIG. 4). In addition, the portions of members 60and 62 that are adjacent to elements 64 (as well as elements 64 and 42)are deflected radially out beyond other portions of the connector insidethe side wall of conduit 202, thereby causing the extreme distal end ofgraft 104 to similarly flare out inside that side wall. This outwardflaring of portions of connector 10 and graft 104 helps secure theconnector and graft to the side wall of conduit 202, and also helps sealthe graft to the conduit. The axial shortening of connector 10 thataccompanies annular enlargement ensures that graft 104 is drawn intosecure and fluid-tight engagement with conduit 202. The free ends ofmembers 42 preferably penetrate the side wall of conduit 202 to furthersecure connector 10 and graft 104 in the aperture in the side wall.Members 50, 52, 56, and 24 may also flare out somewhat outside the sidewall of graft 202 to help ensure that graft 104 remains open where itconnects to conduit 202. Further details with regard to the installationof connector 10 are described in U.S. Pat. No. 6,113,612, incorporatedby reference above.

The next step in use of apparatus 14 is to deflate balloon 18 a andwithdraw all of elements 14, 17 a, and 18 a (e.g., by pulling themproximally out of graft 104). The nose portion 180 may be withdrawn aswell (e.g., pulling portion 180 upstream by catheter 182, as indicatedby the arrow. Alternatively, portion 180′ is pulled proximally out ofgraft 104 if connector 10 is sufficiently enlarged to allow portion 180′to pass within connecter 10, as illustrated in FIG. 16(a)). This leavesthe axial end portion of graft 104 connected to the side wall of conduit202 by annularly enlarged connector 10 as shown in FIG. 16. Inparticular, in this example connector 10 provides an end-to-sideanastomosis between graft 104 and conduit 202. Body fluid from graft 104is able to flow into conduit 202 via this connection. Connector 10presses graft 104 radially outward against the aperture through the sidewall of conduit 202 all the way around that aperture, thereby preventingbody fluid from leaking out of conduits 120 and 202. Connector 10 alsoprevents the end of conduit 120 from pulling out of the side wall ofconduit 202.

The proximal attachment of graft 104 to the body conduit, e.g., theaorta 200, by a connector, such as connector 12, is illustrated in FIGS.17-18. A first step in the process may be to side-clamp the aorta 200 toallow perfusion while controlling blood loss during the deployment ofthe connector.

A next step in the installation of graft 104 may be to pierce conduit200 with the sharpened end of guide wire 162. Guide wire 162 may bedeployed from inside conduit 200 to the outside thereof by the use of acatheter arrangement substantially similar to catheter 152, describedabove with respect to FIGS. 10-11.

Graft installing apparatus 16 is inserted through the surgical accessopening such that a portion of apparatus passes through side branch 105c of graft 104 to access the interior or connector 12, which is attachedto the axial end portion of the graft 104. The step may be performedwith the end portion of graft 104 entirely within the patient, oralternatively, while the end portion of graft 104 is extending outsideof the patient through the surgical access opening.

A nose portion (not shown), similar to portion 180, described above withrespect to FIGS. 13-14, may be helpful to assist in the insertion of anaxial portion of connector 12 through the wall of conduit 200.Alternatively, an incision may be made in conduit 200 by a scalpel orother sharpened instrument inserted through the surgical access openingor percutaneously from the inside to the outside of the conduit 200. Asdescribed above for the installation of connector 10 (FIG. 14), members94 of connector 12 act as “stops” in order to assist in positioning apredetermined axial portion of connector 12 in the conduit wall. Balloon18 b is expanded substantially as described above with respect to FIG.15, in order to expand connector and make the fluid-tight connectionbetween conduit 200 and graft 104.

As illustrated in FIG. 18, expansion of balloon 18 b expands connector12 such that the free ends of members 82 preferably penetrate the sidewall of conduit 200 to further secure connector 12 and graft 104 in theaperture in the side wall. Members 67, 68, and 69 may also flare outsomewhat outside the side wall of graft 200 to help ensure that graft104 remains open where it connects to conduit 200. The balloon catheter17 b and balloon 18 b are removed from the anastomosis site (e.g., bypulling out through the graft 104. Side branch, such as side branch 105c, may be closed by suturing, stapling, the application of clips, orother means known in the art. FIG. 19 illustrates the complete coronaryartery bypass graft, allowing the flow of arterial blood from aorta 200,through graft 104 to supply coronary artery 202 downstream of thenarrowing 204.

According to another embodiment of the present invention, the steps ofinstalling guide member 160/162 from inside conduit 202 may be omitted.For such an alternative embodiment, guide wire 160/162 may be installedfrom the outside to the inside of conduits 200 and/or 202 by the use ofa sharpened instrument, such as a scalpel, to make an incision in theconduit. Subsequently, the guide wire is inserted through the incision.According to yet another alternative embodiment, the guide wire may bedeployed entirely percutaneously, i.e., passed along the patient'svascular system and then deployed from inside a first body conduit tothe outside thereof by passing through the wall of the first conduit.The guide member is then directed to the second conduit by a steerabledevice, and passes through the wall of the second conduit. This isdescribed in greater detail in Sullivan et al. U.S. Pat. No. 6,120,432,which is incorporated by reference in its entirety herein.

An alternative embodiment of the invention is illustrated in FIG. 20.Apparatus 300 is configured to make an anastomotic connection betweengraft 104 and two sections of body conduit with connectors 10 and 12.Apparatus 300 may be employed percutaneously along the patient'svascular system. Alternatively, apparatus may be introduced throughsurgical access or deployed percutaneously and installed with assistancefrom instrumentation inserted through surgical access openings.

Apparatus 300 includes graft installing apparatus 314, which is usefulfor deploying connector 10, and graft installing apparatus 316, forinstalling connector 12. Apparatus 300 is substantially identical toapparatus 100, with some of the differences described herein. Forexample, apparatus 300 allows deployment of both connectors 10 and 12from one axial end of the graft 104. Graft installing apparatus 314 andgraft installing apparatus 316 are independently operable, as will bedescribed in greater detail below.

Graft installing apparatus 314 includes a balloon catheter 317 having aconnector expanding balloon 318 attached to the end. Balloon 318 may beremotely expanded from the proximal portion 319. As FIG. 20(a)illustrates, balloon catheter 317 (and balloon 318, not shown in FIG.20(a)) are configured with an axial opening 315 which allows guidemember 160 to pass coaxially therethrough. Graft installing apparatus316 is substantially similar to apparatus 314. Expandable balloon 322may be remotely expanded from a proximal portion 324 connected by aballoon catheter 320. FIG. 20(a) illustrates that balloon 322 andballoon catheter 320 are configured with an axial opening 323 whichallows balloon catheter 317 to pass coaxially therethrough. The axialopening 323 allows balloon 322 and balloon 318 to be shifted axiallywith respect to one another, e.g., to accommodate different length graftconduits 104.

A desirable feature of structure 300 is the fact that the proximal anddistal connector delivery components are independent of one another interms of deployment controls. The distal connector delivery anddeployment components are coaxially inside the proximal connectordelivery and deployment components. After graft 104 has been attached toconnectors 10 and 12, the space between the respectively associatedportions of structure 300 can be adjusted to add or remove graft lengthbetween the connectors as needed.

FIGS. 20 and 20(a) also illustrate inflation control sleeve 310surrounding an axial portion of balloon 322. Selective inflation ofballoon 322 may be achieved, wherein the portion of balloon 322 that isexposed from sleeve 310 may expand while the portion of balloon 322 thatis surrounded by sleeve 310 is restrained against expansion. Thisselective inflation of balloon 322 allows connector 12 to be expanded instages, as will be described in greater detail below.

An early stage in an illustrative coronary artery bypass procedure inaccordance with the invention includes the accessing the distalanastomosis location, e.g., at the coronary artery. The installation ofthe guide member 160 is substantially described above with respect toFIGS. 9-11, above. Thus catheter 152 and guide member 160 areillustrated in FIGS. 21-23, although it is understood that the methodaccording to the invention may be carried out without the use of guidemember 160.

A later stage in the process includes accessing the aortic end of thedesired bypass around narrowing 204. (See also Berg et al. U.S. patentapplication Ser. No. 09/014,759 (293/029), filed Jan. 28, 1998, which isincorporated by reference in its entirety herein and U.S. patentapplication Ser. No. 09/187,364 (293/036), incorporated by referenceabove, for additional and/or alternative apparatus and/or methods usablein the aortic access that will now be described.) Catheter orcatheter-like structure 300 is introduced intraluminally into thepatient's circulatory system and advanced to the aorta as shown in FIG.21. Catheter 300 is preferably introduced into the patient at a locationremote from the coronary area, e.g., into the patient's vascular systemat the leg and introduced into a femoral artery.

As illustrated in FIG. 21, catheter 300 is pushed into the patient untilits distal portion is adjacent the inside surface of the wall of theaorta 200 where it is desired to connect the aortic end of the bypassgraft around narrowing 204. Needle catheter 302 is then pushed distallyso that its sharpened distal end portion passes through the wall ofaorta 200. The next step is to push the distal portion of pilot wire 304out of the distal end of needle catheter 302.

Subsequently, cutter catheter 306 is pushed in the distal direction sothat a sharpened distal end of catheter 306 makes an annular cut throughthe wall of aorta 200 as shown in FIG. 22. As indicated by the arrow,cutter catheter 306 may be provided with threads so that rotating thecutter catheter “pulls” the catheter distally through the wall of theaorta 200. The distal portion of cutter catheter 306 tends to followpilot wire 304 in the space between aorta 106 and pericardial membrane(not shown) to prevent cutter catheter 306 from inadvertently cuttingthrough the pericardial membrane. The cutter catheter shaft 306functions as a plug through the aperture in the aorta wall that thecutter catheter has formed. This prevents blood flow from the aorta intothe pericardial space. The distal portion of aortic access catheter 308is pushed distally through the aperture in the aorta wall that thecutter catheter formed, and helps to maintain a fluid-tight seal betweenthe aortic access catheter 308 and the aorta.

When catheter 308 is satisfactorily placed in aorta 200, the physicianmay withdraw catheter 306, cannula 302, and wire 304, as illustrated inFIG. 23 (see, for example, Berg et al. U.S. Pat. No. 6,013,190, which ishereby incorporated by reference herein in its entirety).

A further step is shown in FIG. 24 and involves insertion of snarestructure 320 axially through the lumen of aortic access catheter 308,starting from the proximal portion of the catheter, until a distalportion of structure 320 extends from the distal end of catheter 308into the space between artery 200 and pericardial membrane (not shown).Structure 320 is preferably steerable (at least in its distal portion),and may include optical or video components to help the physician guidethe distal portion of structure 320 to the vicinity of the distalportion of catheter 152. The snare loop 322 on the distal end of wire324 may be extended from the surrounding snare sleeve 326, as shown inFIG. 24, when the distal-most portion of sleeve 326 has reached thevicinity of catheter portion 152.

Continued distal pushing of guide member 160 causes the portion outsidecoronary artery 202 to pass through snare loop 322. Snare loop 322 issubsequently withdrawn into snare sleeve 326, thereby interengagingguide member 160 and snare wire 324. Snare 320 is withdrawn into aorticaccess catheter 308, thereby creating a single longitudinal memberextending across the proposed anastomosis site. Further details aredescribed in U.S. patent application Ser. No. 09/187,364 (293/036),incorporated by reference above.

A balloon access catheter may be deployed to dilate the opening in thecoronary artery substantially as described with respect to FIG. 12,above. As illustrated in FIG. 25, the distal portion of graft installingapparatus 300 is inserted along the patient's vascular system over guidemember 160. According to a preferred embodiment, nose portion 180 may beadvanced to dilate the coronary artery 202 at the distal anastomosislocation, as illustrated in FIG. 25. The distal anastomosis is madebetween the graft 104 and the conduit 202, substantially as describedwith respect to FIGS. 13-16. For example, balloon 318, described above,is expanded to deform and deploy connector 10 substantially as describedabove for deforming connector 10 by expanding balloon 18 a/18 b. Ballooncatheter 317 is configured to coaxially pass through balloon 322 andballoon catheter 320.

Graft 104, graft installing apparatus 314 and connector 12 are advancedfrom aortic access catheter 308, such that the connector is positionedbeyond the distal end of catheter 308, as illustrated in FIG. 26. Asdescribed above, an inflation control sleeve 310 surrounds an axialportion of balloon 322 nearest aortic access catheter 308. Fluid or airis introduced into balloon 322, thereby expanding the portion of balloon322 exposed from sleeve 310. Consequently, the proximal portion ofconnector 12 is expanded by balloon 322, as shown in the FIG. (Thedistal axial portion of balloon 322 is restrained by the inflationcontrol sleeve and is not expanded, nor is the distal axial portion ofconnector 12.) The expanded proximal portion of connector 12 becomesannularly larger than the aortic access catheter 308. As indicated bythe arrow, the aortic access catheter 308 and the connector 12 may bemoved proximally into the aorta 200. When moved into the aperture of theaorta, the expanded proximal portion of connector 12 helps to maintainthe fluid-tight seal around the aperture in the aorta, and to controlblood loss.

FIG. 27 illustrates the position of the connector 12 with respect to thewall of aorta 200. The free ends 92 of connector 12 acts as “stops” toprevent the connector 12 from advancing further into the aorta 200, andtherefore assist in properly positioning connector 12 with respect tothe aorta 200.

Inflation control sleeve 310 is retracted into the lumen of the aorta toexpose the distal portion of balloon 322. Balloon 322 is subsequentlyexpanded (as illustrated in the FIG.), thereby annularly expanding thedistal portion of the connector, as illustrated in FIG. 28. Connector 12thus forms an anastomotic connection between graft 104 and aorta 200.The installing apparatus, such as inflation control member 310, aorticaccess catheter 308, and expandable member 322 are subsequently removedfrom the patient.

It will be understood that the foregoing is only illustrative of theprinciples of the invention and that various modifications can be madeby those skilled in the art without departing from the scope and spiritof the invention. For example, the invention can be used to add a graftto the patient's circulatory system elsewhere than between the aorta anda coronary artery as has been specifically shown and described above.Similarly, although particular examples of connector types have beenshown herein, many other forms of connectors can be used instead ifdesired.

What is claimed is:
 1. A method for making an anastomotic connectionbetween a first tubular fluid conduit and a second tubular fluid conduitin a patient, the method comprising: attaching a connector to an axialend of the first tubular fluid conduit such that an interior portion ofthe connector is substantially accessible to an interior lumen of thefirst tubular fluid conduit, wherein the attaching comprises: providingmembers on the connector having free end portions that are directedradially outward; and piercing the axial end portion of the firsttubular conduit at annularly spaced locations; passing a portion of theconnector through an opening in the side wall of the second tubularfluid conduit; and expanding a portion of the connector by accessing theinterior of the connector through an opening in the side wall of thefirst tubular conduit.
 2. The method defined in claim 1, wherein thefirst tubular fluid conduit has a side branch located at the medialportion, and the expanding the portion of the connector comprisesaccessing the interior of the connector through the side branch of thefirst tubular fluid conduit.
 3. The method defined in claim 1, whereinthe expanding the portion of the connector comprises: providing anexpandable structure having a balloon member disposed adjacent theinterior of the connector and an elongated portion configured to passthrough the opening in the side wall of the first tubular fluid conduitfor remotely expanding the balloon member; and expanding the balloonmember.
 4. The method defined in claim 2, further comprising: after theexpanding the portion of the connector, removing the expandablestructure from the first tubular fluid conduit and closing the sidebranch of the first tubular fluid conduit.
 5. The method defined inclaim 1, wherein the attaching further comprises engaging the side wallof the second tubular fluid conduit when a predetermined axial portionof the connector has passed through the opening in the side wall of thesecond tubular fluid conduit.
 6. The method defined in claim 1, furthercomprising: before the passing the portion of the connector through theopening in the side wall of the second tubular fluid conduit, piercingthe second tubular fluid conduit.
 7. The method defined in claim 6,wherein the piercing the second tubular fluid conduit comprises piercingthe second tubular fluid conduit by advancing an elongated member fromthe interior of the second tubular fluid conduit to the exteriorthereof.
 8. The method defined in claim 6, wherein the piercing thesecond tubular fluid conduit comprises piercing the second tubular fluidconduit by advancing an elongated member from the exterior of the secondtubular fluid conduit to the interior thereof.
 9. The method defined inclaim 7, further comprising: after the step of piercing the secondtubular fluid conduit, enlarging the opening in the side wall of thesecond tubular fluid conduit.
 10. The method defined in claim 9, whereinthe enlarging the opening comprises expanding a balloon memberpositioned in the opening in the side wall of the second tubular fluidconduit.
 11. The method defined in claim 1, wherein the expanding aportion of the connector comprises expanding the portion of theconnector disposed within the second tubular fluid conduit such that themembers engage the interior side wall of the second tubular fluidconduit and the free end portions pierce the side wall.
 12. The methoddefined in claim 11, further comprising: providing a sheath structureconfigured to surround a distal portion of the connector and the freeend portions, wherein the passing the portion of the connector throughthe opening in the side wall of the second tubular fluid conduitcomprises passing the connector and the sheath structure through theopening in the side wall of the second tubular fluid conduit such thatthe sheath structure surrounds the free end portions during the passing.13. The method defined in claim 12, further comprising: after thepassing the sheath structure through the opening in the side wall of thesecond tubular fluid conduit, moving the sheath structure to a locationspaced apart from the connector.
 14. The method defined in claim 1,further comprising: attaching a second connector to a second axial endof the first tubular fluid conduit such that an interior portion of theconnector is substantially open to an interior lumen of the firsttubular fluid conduit; passing a portion of the second connector throughan opening in the side wall of a third tubular fluid conduit; andexpanding a portion of the second connector by accessing the interior ofthe second connector through the opening in the side wall of the firsttubular fluid conduit.